Using Intervention Mapping to Develop an Implementation Strategy to Improve Timely Uptake of Streamlined Birth-dose Vaccines in the Democratic Republic of the Congo

"...ultimate objective was to share findings with the national government to support modifying the national immunization policy and administration guidelines surrounding newborn immunization in Kinshasa Province, the DRC."

In Sub-Saharan Africa (SSA), timely uptake of birth-dose (BD) vaccines (hepatitis B (HepB-BD), Bacillus Calmette-Guerin (BCG), and first oral polio dose, or OPV0) remains an issue. This paper documents the development of VANISH-BD (Vaccination of Newborn - Innovative Strategies to Hasten Birth-Dose vaccines' delivery), an implementation strategy to streamline BD vaccine delivery in a timely manner (within 24 hours of delivery) using an intervention mapping (IM) approach. It reports on the development of the intervention in Kinshasa Province, Democratic Republic of the Congo (DRC), where HepB-BD is as of this writing not part of the national immunisation schedule.

IM is an iterative and cumulative process that is grounded in conceptual models, behavioural theory, and engagement with key stakeholders and the community members to develop context-appropriate interventions. Community-based participatory research (CBPR) provides a link through which evidence-based research, community members, and leaders can combine to develop sustainable and context-specific interventions. IM emphasises applying CBPR principles by engaging community stakeholders throughout the intervention's development, implementation, and evaluation.

IM uses outputs from previous steps to inform subsequent steps in the implementation process. The six steps of the IM process include:

1. A needs assessment and logic model of the problem - The PRECEDE (Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation) model guided the first step of IM. PRECEDE categorises factors influencing the health problem using three levels: individual (predisposing), interpersonal (enabling), and structural/policy (reinforcing) factors inherent in health behaviours and interventions.

The researchers conducted interviews with expectant mothers and informants at the health facility, health zone, and national level (n = 30) across Kinshasa Province. These interviews explored determinants to the uptake of currently available BD vaccines - BCG and OPV0 - and perceived barriers to future uptake of HepB-BD vaccine from various perspectives. Findings highlighted significant barriers to the uptake of BD vaccines, including lack of communication between delivery and vaccine departments, limited understanding of vaccines among mothers and communities, regular stockouts and lack of storage capacity, and inconsistent vaccine fees across facilities.

The researchers also conducted regression analyses leveraging longitudinal data from a continuous quality improvement study to assess the barriers to the timely administration of currently available BD vaccines, BCG and OPV0. At the individual level, results showed that a mother's education, wealth, and proximity to a facility influenced the timely uptake of vaccines. A mother visiting a facility with religious affiliation and high general and immunisation-specific readiness also impacted the timely uptake of vaccines.

2. Development of performance and change objectives - The researchers employed the main findings from the needs assessment to define BD vaccine uptake behaviours for facility staff and mothers; they also defined study objectives, described determinants of the identified behaviours, and developed matrices of change. In this step, the researchers aimed to develop, implement, and examine the feasibility of an intervention streamlining BD vaccines, including HepB-BD, BCG, and OPV0, within 24 hours of delivery for newborns in Kinshasa. They achieved this objective by using a two-pronged approach targeting facilities and leveraging community outreach. To define change objectives, the researchers reported outcomes from needs assessment findings to community members. They held an open forum with health staff at the health zone and facility levels to elicit feedback and discuss reasonable change objectives. Normative beliefs to promote this transformation include instilling the belief that other leaders and facilities are actively endorsing the expansion of BD vaccine services.

3. Selection of theory-based methods and strategies - The researchers identified theoretical concepts and practical applications to guide the intervention's implementation. The community and health staff required sustained behaviour change to improve timely BD vaccine uptake. Therefore, they chose two relevant theories, the Theory of Planned Behavior (TPB) and the Social Cognitive Theory (SCT). Using both theories, they organised determinants of behaviour change and theory-based methods with practical application of behaviour change techniques to overcome targeted barriers. Using the theoretical frameworks, they grouped our strategies into three levels to impact sustained behavioural change: increasing knowledge, increasing self-efficacy, and changing outcome expectations.

4. Development of programme components and materials - The next task was to design educational and training materials and associated protocols for use by other policymakers and implementers aspiring to improve the uptake of timely and streamlined BC vaccines. Based on the findings from the needs assessment, two programme components were deemed important: (i) a need to focus on behavioural aspects through individual and community awareness; and (ii) more buy-in from and guidance at the facility level. The associated strategies (VANISH-BD) included developing adopter and implementer relationships, identifying intervention champions, holding training sessions, and modifying educational materials, guidelines, and protocols.

For example, the researchers developed new educational posters and scripts to be used by antenatal care (ANC) staff to educate mothers about the risks of hepatitis B, polio, and tuberculosis and the benefits of the vaccines to prevent these diseases. In addition, because their research suggested that the community plays a significant role in a mother's decision to vaccinate her infant, the researchers leveraged community health workers (CHWs) to partner with community leaders - through churches and schools - to further disseminate information about newborn vaccines.

5. Development of the implementation and adoption plan - The objective was to implement the complete intervention in all study facilities and achieve sustainability through the maintenance of champions and training.

6. Development of the evaluation plan - The evaluation plan will be finalised as part of a future study, but, in brief, the researchers will evaluate the feasibility of VANISH-BD through a cluster-randomised controlled trial in Kinshasa Province, DRC, in 12 facilities. They will expose the treatment arm to VANISH-BD, and the control arm will receive the HepB-BD vaccine without the implementation package. The treatment and control facilities will be located in non-contingent catchment areas to ensure community dissemination does not spill over to the control facility territory. The researchers will organise an awareness session to inform the facility staff in the control arm that newborns will receive HepB-BD. The primary outcome will be the proportion of newborns in facilities receiving timely BD vaccines of HepB-BD, BCG, and OPV0.

According to the researchers: "The intervention is contextually relevant, locally produced, sustainable, and designed to improve timely birth-dose vaccine uptake in the DRC. By providing a detailed, stepwise description of the intervention development process, other researchers and implementers may use the findings to adopt the implementation strategy in other relevant settings to facilitate HepB-BD introduction and improve the uptake of streamlined birth-dose vaccines at the facility level."